Products covered by registration projects
- Medical equipment
- Monitoring equipment, portable ultrasound, medical imaging and respiratory equipment.
- In vitro diagnostics
- PCR tests, rapid antigen tests and respiratory combination tests.
- Surgical and dental devices
- Surgical instruments, dental devices and related medical consumables.
- Medicines and other products
- Complementary medicines and PPE products, using the application pathway applicable to each product category.
Team registration experience
Over the past ten years, the team has supported overseas registration for hundreds of medical devices, medicines, IVDs and consumables, including PCR tests, colloidal-gold antigen tests and respiratory combination tests.
Who we support
- First Australian entry: confirm pathway, applicant and preparation sequence
- Existing CE or FDA evidence: check scope and consistency with products intended for Australia
- Existing ARTG inclusion: discuss product changes, document updates and post-market coordination
Registration services
- TGA pathway assessment and submission strategy
- Review of classification, technical documentation, labels and instructions for use
- ARTG application preparation, submission coordination, regulatory correspondence and supplementary information management
- Support for post-registration changes, adverse events and ongoing compliance
Scope and deliverables
Based on product and document status, agree stage questions, client inputs, deliverables, contacts and next steps. Confirm scope and fees again for additional models, evidence or other work.
- Pathway assessment: record classification rationale, proposed evidence pathway and matters to verify
- Document review: list files, gaps, owners and version requirements
- Submission coordination: define submission arrangements, regulatory communication and follow-up scope
- Ongoing maintenance: agree changes, compliance support and associated fees separately
Sponsor and post-market arrangements
Sonictec provides Australian Sponsor services, clarifying manufacturer, Sponsor and distributor responsibilities, documentation coordination and ongoing maintenance before engagement. Registration work must align with subsequent supply arrangements.
Prescribed List eligibility
The Prescribed List concerns private health insurance benefits for certain medical devices and human tissue products; it is not a universal reimbursement list. We support applicability assessment, application pathways and preparation. TGA registration and listing eligibility must be assessed separately.
- Initial product and listing eligibility assessment
- Reviewing clinical value and supporting evidence
- Application preparation and communication support
Costs and timing
Provide use, model scope, certificates and evidence, ARTG status and supply timing. Separate service fees, official TGA costs, ongoing Sponsor services and potential testing or translation. Timing depends on documentation, pathway and review; no standard quote or approval promise is made before initial assessment.
Technical documentation preparation
Review product descriptions, labels, technical files, clinical or performance evidence and existing authorizations. Identify gaps against applicable requirements and coordinate supplements with the manufacturer.
Submission and regulatory communication
Progress the application once applicable prerequisites are met, tracking status and coordinating questions and supplementary information. TGA conducts the regulatory assessment and makes the decision; processing depends on the application.
Collaboration process and stage deliverables
- Initial document discussion: provide intended use, model overview, certificates and Australian progress. Begin with an overview; exchange technical files as agreed.
- Scope and quotation: define pathway assessment, document review or submission deliverables and itemise service fees, official costs and external work.
- Project delivery: agree contacts, document versions and responsibility for supplements, following progress in stages; check Sponsor and documentation conditions before applying.
- Ongoing coordination: coordinate regulatory questions, product changes and maintenance as agreed; confirm additional work separately.
View the initial consultation checklist Understand service fees versus official fees
Related submission cases
Explore selected casesFrequently asked questions
Does Sonictec support TGA registration for Chinese manufacturers?
Yes. Sonictec can discuss Australian registration preparation with medical device and IVD manufacturers in Chinese, including documentation and Sponsor arrangements. The first discussion establishes intended use, model scope, available evidence and Australian progress, then defines whether the engagement covers pathway assessment, document review or application coordination. Technical writing, third-party testing and ongoing support should be specified separately in the agreed scope, together with responsibilities, deliverables and fees.
What information is needed for an initial quote?
Start with a product catalogue, intended use, model overview and list of existing certificates, together with any ARTG entry or Sponsor arrangement and the problem you want to address. Pricing requires an understanding of product and evidence scope, rather than a product name alone. After agreeing how to exchange files, review certificate validity, model coverage and documentation gaps, then separate consulting, official fees, testing, translation and ongoing support in the budget.
Can a product with CE or FDA documentation be sold directly in Australia?
Overseas regulatory documents may support an Australian application, but do not replace Australian market access requirements. Check the document type, issuer, validity and covered products against the proposed Australian classification, intended use and evidence requirements. Saying that a product has CE marking or has been through the FDA is not sufficient to establish a pathway. Review the actual documents and model list to identify usable evidence and gaps, and meet applicable ARTG and supply requirements before supplying.
Official sources:TGA: using specific overseas authorization evidence ；TGA: steps to supply medical devices for Sponsors
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Are official annual charges and Sponsor service fees the same?
List them separately in the budget. TGA annual charges are regulatory charges, with applicable amounts and exemptions checked against the current schedule. Sponsor service fees cover the ongoing work agreed with the provider, such as documentation coordination, regulatory communication and post-market support. Compare billing periods, covered entries or products, taxes and additional-work charges. A quote should distinguish initial application work, official charges and continuing services rather than imply that one total covers every future cost.
Official sources:TGA: current application fees and annual charges
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Does TGA registration automatically secure Prescribed List access?
ARTG inclusion and the Prescribed List serve different purposes. Australian market access does not automatically establish eligibility for private health insurance benefits under the List. First assess whether the product and use fall within the List’s scope and criteria, then examine its evidence and application requirements. Regulatory access, payment pathways and hospital procurement can be planned together, but each requires its own assessment, budget and responsibilities.
Official sources:Australian Department of Health: Prescribed List
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Can multiple models be covered by one ARTG entry?
Grouping models under one ARTG entry depends on the rules for a kind of device, not just similar names or appearance. Review the Sponsor, manufacturer, classification and GMDN code; some high-risk categories also have unique product identifier requirements. Prepare a model matrix showing intended use and key design or performance differences. Reassess coverage when combinations or variants change rather than treating an existing entry as unlimited product coverage.
Official sources:TGA: kinds of medical device and grouping
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How should we respond to a TGA request for additional information?
When additional information is requested, identify each question, deadline and conclusion requiring evidence, then assign document preparation to the manufacturer and relevant contributors. Use a response matrix with owners, versions and section references rather than resubmitting a large file set without answering the questions. Audit selection and evidence needs depend on the application; an information request is not itself a refusal. Follow the actual request and retain the response and correspondence.
Official sources:TGA: application audits and information requests
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When does the TGA registration timeline start?
Separate manufacturer preparation, document review, external testing or auditing and TGA processing in the plan. Official processing time is not the full project duration from a standing start. The TGA identifies completeness, response speed and clinical evidence suitability as factors affecting actual processing. Document existing conditions, gaps, owners and start points, and update the plan as evidence changes. Historical averages provide context, not a guaranteed decision date for an individual product.
Official sources:TGA — Understanding processing timeframes for medical device applications
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Further reading
- Choosing a TGA service provider: scope, fees and ongoing responsibilities
- What is included in a TGA quote? Comparing service fees, official fees and annual charges
- How do TGA registration consulting and an Australian Sponsor differ?
- What should you prepare before a TGA registration consultation?
- What should be checked for TGA when CE or FDA documentation already exists?
- Australian UDI is being phased in: what should Chinese manufacturers check now?
Official references
- TGA: steps to supply medical devices for Sponsors
- TGA: using assessments from comparable overseas regulators
- Australian Department of Health: Prescribed List
- TGA: Post-market responsibilities for medical devices
- TGA: current application fees and annual charges
- TGA: Sonictec Pty Ltd ARTG 483305 record
- TGA: Sonictec Pty Ltd ARTG 408073 record
Sources checked: 2026-09-14. Assess individual products and projects against current applicable requirements.
